Alembic Pharmaceuticals receives USFDA approval for Fingolimod Capsules ANDA

Alembic Pharmaceuticals (Alembic) announced that it has received final approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fingolimod Capsules, 0.5 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis).

Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS). This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients aged 10 years and above. Refer to the label for detailed indication.

Fingolimod Capsules, 0.5 mg, have an estimated market size of US$ 145 million for the twelve months ending December 2025, according to IQVIA.

Alembic has a cumulative total of 237 ANDA approvals from the USFDA, which include 219 final approvals and 18 tentative approvals.

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